Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Victoza® (liraglutide); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90029
    • University of Oulu and Oulu University Hospital, Dept of Children and Adolescents
  • Tampere, Finland, 33520
    • University of Tampere and Tampere University Hospital
  • Turku, Finland, 20520
    • University of Turku and Turku University Hospital
• Sweden
  • Malmö, Sweden, 205 02
    • Lund University and Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 10-30 years of age
• early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)
• not pregnant.

Exclusion Criteria:

• allergic to liraglutide or other ingredients of Victoza®
• diabetic ketoacidosis
• previous treatment in the last three months with any antidiabetic medication other than insulin
• impaired liver or kidney function or on dialysis
• severe heart failure
• severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease
• past or current history of pancreatitis
• serum calcitonin value above normal (>50 ng/l or ≥3.4pmol/l)
• presence of any chronic metabolic, hematologic or malignant disease
• obesity BMI ≥30
• pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
• breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Victoza® (liraglutide); Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30 years, and treated with insulin are treated with Victoza®	Drug: Victoza® (liraglutide); Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
Placebo Comparator: Placebo; Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin are treated with placebo	Drug: Placebo; Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum C-peptide AUC	Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test)	From baseline to 26 and 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored	Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored during the 26 weeks treatment period and 26 weeks follow-up period	From baseline to 26 and 52 weeks
Number of hypoglycemia episodes	Number of hypoglycemia episodes during the 26 weeks treatment period and 26 weeks follow-up period	From baseline to 26 and 52 weeks
Frequency of gastrointestinal side effects	Frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) during the 26 weeks treatment period and 26 weeks follow-up period	12 months
Insulin dose	Insulin dose IU/kg/day	From baseline to 26 and 52 weeks

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Turku University Hospital; Oulu University Hospital; Tampere University Hospital; Skane University Hospital

Publications and helpful links

General Publications

• Kero J, Koskenniemi JJ, Karsikas S, Pokka T, Lou O, Toppari J, Veijola R. INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Diabet Med. 2022 Oct;39(10):e14913. doi: 10.1111/dme.14913. Epub 2022 Jul 22.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Liraglutide; Diabetes Type 1; Early diagnosis; Diabetes, Insulin-Dependent; GLP-1 Analogue
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: LiraT1D10-30; 3-SRA-2014-301-M-R (Other Grant/Funding Number: Juvenile Diabetes Research Foundation International); 2014-004760-37 (EudraCT Number); U1111-1177-0661 (Other Identifier: WHO)